Sr Validation Engineer

Working with Us
Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives. Read more: a Bristol Myers Squibb company is a dynamic biotechnology company headquartered in San Diego CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team RayzeBio aims to be the global leader in radiopharmaceuticals.

Summary
The Senior Validation Engineer will lead validation efforts to support the Radiopharmaceutical facility and GMP operations in Indianapolis. This role is responsible for the development execution and management of commissioning qualification and validation (CQV) documents and protocols for highly specialized facility utility analytical and process equipment. The Senior Validation Engineer utilizes a broad range of engineering disciplines to ensure seamless progression from construction to clinical development and commercial GMP operations. Responsibilities include onboarding advanced technologies (such as isolator-based sterile systems) guiding process development supporting GMP operations managing investigation and CAPA processes driving continuous improvement initiatives and supporting future facility expansion projects.

Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
Serve as validation subject matter expert for the commissioning and qualification of a 60000 sq. ft. office warehouse and GMP Radiopharmaceutical production facility including isolator-based aseptic processes.
Lead the strategy and implementation of CQV programs for GMP spaces: office warehouse development quality control sterility/microbiology and GMP production with emphasis on isolator and containment technologies.
Direct and coordinate consultant(s) and project teams in the execution of validation activities and continuous improvement initiatives.
Partner cross-functionally with Engineering QC and Operations to develop and implement new processes and onboarding of new technologies including advanced isolator systems.
Provide senior-level validation oversight and support for ongoing development and GMP manufacturing operations.
Guide mentor and cross-train team members to broaden validation capabilities including process validation cleaning validation CSV and QC asset validation.
Own and drive key validation areas and projects establishing and maintaining best practices for isolator technology and sterile operations.
Lead complex deviation investigations data reviews CAPA management change controls and ensure robust technical documentation.
Author review and approve GMP documentation including SOPs forms protocols technical documents reports deviations CAPA and change controls.
Support and represent the validation function during Health Authority inspections and audits.
Monitor and report on department KPIs to drive performance improvement.
Execute and provide technical support for equipment and process validation including hands-on experience with isolator-based sterile filling and process systems.

Education and Experience
BS or MS in a scientific discipline or engineering field (advanced degrees preferred).
Minimum 5 years of experience in radiopharmaceutical or injectable GMP manufacturing environment.
Minimum 5 years of validation experience in GMP environments with direct isolator technology and aseptic processing experience required.

Skills and Qualifications
Advanced technical writing and documentation skills.
Expert knowledge of regulatory guidelines for validation risk management and isolator-based processes.
Proven leadership capabilities independent mindset and effective problem-solving abilities.
Highly organized professional with exceptional communication interpersonal and mentoring skills.
Track record of leading teams and cross-functional projects in GMP environments.
Strong multi-disciplinary engineering background with specific expertise in isolator systems for sterile manufacturing.
High professional ethics integrity and ability to maintain confidential information.

Work Environment
The noise level in the work environment is usually moderate.

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If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical pharmacy dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability life insurance supplemental health insurance business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays Global Shutdown Days between Christmas and New Years holiday up to 120 hours of paid vacation up to two (2) paid days to volunteer sick time off and summer hours flexibility. Parental caregiver bereavement and military leave. Family care services such as adoption and surrogacy reimbursement fertility/infertility benefits support for traveling mothers and child elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

Uniquely Interesting Work Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

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BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

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